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510(k) K220063

Single Use Cytology Brush by Zhejiang Chuangxiang Medical Technology Co., Ltd. — Product Code FDX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2022
Date Received
January 10, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Cytology Brush
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To collect cells for cytological evaluation.

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Other clearances for product code FDX

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